Two months after Bayer and its Finnish partner Orion reported positive late-stage data for its prostate cancer drug darolutamide, the German drugmaker has convinced the FDA to grant priority review on its NDA.

Like Pfizer’s Xtandi and J&J’s Erleada, darolutamide is a non-steroidal androgen receptor inhibitor for prostate cancer patients whose disease has not spread but continues to grow despite low testosterone levels. But unlike the more entrenched drugs — both billed as potential blockbusters — Bayer says its drug has “inherently different pharmacokinetics,” leading to less CNS toxicity and lower risk for drug-drug interactions.

In the ARAMIS study, the drug slashed the risk of metastasis or death by 59%, while achieving a median metastasis-free survival of 40.4 months versus 18.4 months in the placebo arm. The 1,509 patients in the trial were already being treated with androgen deprivation therapy as standard of care, and are at high risk for developing metastatic disease, according to Bayer.

Bayer didn’t break down the numbers on the secondary endpoints — overall survival, time to pain progression and time to initiation of first cytotoxic chemotherapy — but claimed the trends were favorable to the drug.

Darolutamide is a top Phase III drug for Bayer, which already sells Xofigo for metastatic prostate cancer. If approved, Bayer will be responsible for sales while Orion takes care of manufacturing. Orion, which first out-licensed the drug in 2014, also has the option to co-promote in Europe while earning sales milestones and royalties globally.

Bayer has filings at the EMA and Japan’s Ministry of Health, Labor and Welfare, while continuing to work with regulators around the world. It’s also testing darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC); the trial is expected in wrap in 2022.

Sign in to Endpoints News

Request a magic link

Enter your email below to get a Magic link which lets you sign in quickly without using a password.Please note the Magic link is one-time use only and valid for only 24 hours.
Email:

← Go back

Set a new password

We will send you a link, with which you will be able to set a new password.Please note this link is for one-time use only and valid for only 24 hours.
Email:

← Go back

We produce two daily email newsletters designed to give you a complete picture of what's important in biopharma. It's free to subscribe and never any spam. Join 51,200+ biopharma executives who read Endpoints News every day.